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Drug Use-Results Survey on Picoprep® Combination Powder

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT03631446
Collaborator
(none)
1,298
Enrollment
1
Location
52.1
Actual Duration (Months)
24.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this survey is to confirm safety and efficacy with patients who are administered the Picoprep® for cleansing of intestinal contents for preparation of colonoscopy and colorectal surgery.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sodium Picosulfate, Magnesium Oxide and Citric Acid

Study Design

Study Type:
Observational
Actual Enrollment :
1298 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Drug Use-Results Survey on Picoprep® Combination Powder
Actual Study Start Date :
Aug 29, 2017
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Patients administered Picoprep® for bowel cleansing

Patients administered Sodium Picosulfate, Magnesium Oxide and Citric Acid for bowel cleansing

Drug: Sodium Picosulfate, Magnesium Oxide and Citric Acid
Combination powder for oral solution
Other Names:
  • Picoprep®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bowel cleansing assessment for colonoscopy [48 hours after drug administration]

      Assessment of each part of large intestine using a bowel cleanliness rating scale

    2. Bowel cleansing assessment for colorectal surgery [48 hours after drug administration]

      Assessment of each part of large intestine using a bowel cleanliness rating scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Patients who are administered the Picoprep® for cleansing of intestinal contents for preparation of colonoscopy and colorectal surgery.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site (there may be other sites in this country) Shibuya Tokyo Japan

    Sponsors and Collaborators

    • Ferring Pharmaceuticals

    Investigators

    • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ferring Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03631446
    Other Study ID Numbers:
    • 000311
    First Posted:
    Aug 15, 2018
    Last Update Posted:
    Jan 18, 2022
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Picosulfate sodium
    Magnesium Oxide
    Citric Acid
    Sodium Citrate

    Study Results

    No Results Posted as of Jan 18, 2022